Calcium Carbonate Chewable Antacid Tablet, Chewable
FDA Label NDC 57896-763

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Calcium Carbonate Chewable Antacid (NDC 57896-763). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

  • temporarily relieves: acid indigestion, heartburn, sour stomach

Warnings

Ask a doctor before use if you
• have kidney disease
• are taking prescription drugs; antacids may interact with certain prescription drugs

Stop use and ask a doctor if • symptoms last more than 2 weeks.

When using this product • do not use the maximum dosage for more than 2 weeks

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed recommended dose
• adults and children 12 years of age and older: chew 2-4 tablets as symptoms occur
• repeat hourly if symptoms return, or as directed by a physician
• do not take more than 15 tablets in a 24 hour period
• children under 12 years: consult a doctor

Other Information

• each tablet contains: calcium 200 mg
• store at room temperature
• for institutional use only
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive Ingredients

assorted flavors, dextrose, D and C Yellow no. 10 lake, FD and C Blue no. 1 lake, FD and C Red no. 40 lake, FD and C Yellow no. 6 lake, magnesium stearate, maltodextrin. May also contain cellulose, FD and C Yellow no. 5 lake (tartrazine), stearic acid, sugar.

Package Label

GERICARENDC 57896-763-15CALCIUM CARBONATECHEWABLE ANTACIDASSORTED FLAVORScompare to active ingredient in TUMS regular strength tablets150 Tablets500 mg each

* Please review the disclaimer below.